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- (CVAY736A2301E1) A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients with Sjögren’s Syndrome
Clinical Trial
(CVAY736A2301E1) A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients with Sjögren’s Syndrome
The Primary Purpose of this 3-year treatment extension study is the continued evaluation of the safety and tolerability of treatment with ianalumab 300 mg monthly or evry 3 months. An additional purpose is to explore the long-term efficacy of both dosing regimens of ianalumab 300 mg. Study Indication: Sjogren's syndrome
- Nervous System
- Autoimmune Disease
- B-cell Depleting Therapy
- BAFF Receptor
- BAFF-R
- Dryness
- ESSDAI
- ESSPRI
- Fatigue
- Ianalumab
- Monoclonal Antibody
- NEPTUNUS
- Sicca Syndrome
- Sjögren’s Syndrome
- SSSD
- VAY736
Eligibility Criteria
- Key Inclusion Criteria: 1. Signed informed consent prior to participation in the extension study. 2. Participants must have participated in either one of the two NEPTUNUS core studies, CVAY736A2301 or CVAY736A2302, and must have completed the entire treatment up to Week 48 without treatment discontinuation in core NEPTUNUS srudies. 3. In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy. Key Exclusion Criteria: 1. Use of therapies excluded by the NEPTUNUS-a and NEPTUNUS-2 study protocols 2. Plans for administration of live vaccines during the study period. 3. Pregnant or nursing (lactating) women, 4. Women of child -bearing potential
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